Selection of hypertensive patients for treatment with renal denervation

ABSTRACT

Methods, systems, devices, assemblies and apparatuses for treatment of hypertension in a patient using renal denervation. The therapeutic assembly includes an energy delivery element. The energy delivery element is configured to provide renal denervation energy to a nerve within a blood vessel of a patient. The therapeutic assembly includes a controller. The controller is coupled to the energy delivery element. The controller is configured to determine that the hypertension in the patient is orthostatic. The controller is configured to apply renal denervation energy to the patient using the energy delivery element.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application claims priority to and the benefit of U.S. ProvisionalApplication No. 62/850,195, titled “METHOD TOR SELECTION OF HYPERTENSIVEPATIENTS FOR TREATMENT WITH RENAL DENERVATION,” filed on May 20, 2019,and the entirety of which is hereby incorporated by reference herein.

BACKGROUND 1. Field

This specification relates to a system, a device, a method and/or anapparatus for determining and selecting hypertensive patients that areresponsive to treatment with renal denervation.

2. Description of the Related Art

Various non-invasive approaches have been developed to perform renalsympathetic denervation (RDN) procedures for the reduction of high bloodpressure (BP) in patients at risk for cardiovascular complications anddeath due to inadequate control of their hypertension. Renal denervationis a minimally invasive procedure to treat resistant hypertension.During renal denervation, a nurse, doctor, technician or other hospitalstaff (or “clinician”) uses stimuli or energy, such as radiofrequency,ultrasound, cooling or other energy, to perform ablation within therenal arteries. This reduces activity of the nerves surrounding thevessel, which has been shown to result in a decrease in blood pressureand other benefits. The clinician uses the renal denervation device todeliver the stimuli or energy to the treatment site, e.g., through oneor more electrodes of the renal denervation device. The stimuli at thetreatment site may pass through the wall of the blood vessel, which mayresult in various resultant RDN-related depressor effects. The resultantRDN-related depressor effects include efferent sympathetic nerveablation causing decrease in nocturnal BP, and afferent sympatheticnerve ablation, resulting in the central sympatholytic activity causingdecrease in daytime BP. Not all patients with refractory or resistanthypertension, however, may benefit from RDN. Therefore, it is useful toidentify patients whom likely benefit from a renal denervationprocedure.

Additionally, it is important to understand the patient's response tothe stimuli in order to determine the best and most effective course oftreatment to administer to predict the overall effectiveness of theadministered treatment on the patient. This allows the doctor, nurse orother healthcare professional to adjust, modify and/or otherwise monitorand control the treatment to provide for effective treatment anddetermine a likelihood of success of the course of treatment. Thus, theselection of patients and the determination of treatment for the patientis important to provide and administer effective treatment.

Accordingly, there is a need for a system, apparatus and/or method tomanage, adjust or otherwise control the selection of patients and toadminister treatment including the delivery of renal denervation energyto provide for effective treatment that accurately mirrors theanticipated result on a parameter of the patient or a disease condition.

SUMMARY

In general, one aspect of the subject matter described in thisspecification is embodied in a method for treatment of hypertension in apatient. The method includes determining that hypertension in thepatient is orthostatic. The method includes applying renal denervationenergy to the patient.

These and other embodiments may optionally include one or more of thefollowing features. The method may include measuring a baseline standingsystolic blood pressure (SBP) of the patient. The method may includemeasuring a baseline supine SBP of the patient. The method may includedetermining that the baseline standing systolic blood pressure (SBP) ofthe patient is greater than the baseline supine SBP by at least 20 mmHgto determine that the hypertension in die patient is orthostatic. Themethod may include determining that the baseline standing systolic bloodpressure (SBP) of the patient is greater thin the baseline supine SBP byat least 10 mmHg to determine that the hypertension in the patient isorthostatic.

The method may include obtaining user input that indicates the baselinestanding systolic blood pressure (SBP), the baseline supine systolicblood pressure (SBP), the baseline standing diastolic blood pressure(DBP) and the baseline supine diastolic blood pressure (DBP). The methodmay include measuring a baseline standing diastolic blood pressure (DBP)of the patient. The method may include measuring a baseline supine DBPof the patient. The method may include determining that the baselinestanding diastolic blood pressure (DBP) of the patient is greater thanthe baseline supine DBP by at least 10 mmHg.

The method may include determining a number of ablations based on diedetermination that the hypertension in the patient is orthostatic. Themethod may include applying the renal denervation energy or choosing notto consider a patient for renal denervation. The application of therenal denervation energy may be based on the number of ablations and theamount of energy to be delivered in each ablation. The method mayinclude applying the renal denervation energy endovascularly,intravascularly or externally. The method may include applying the renaldenervation energy to the patient using at least one of using radiofrequency (RF) ablation, chemicals, cryotherapy or ultrasound.

The method may include determining that the patient is m a supineposition. The method may include measuring a supine blood pressure ofdie patient when the patient is in the supine position. The method mayinclude waiting a period of time before measuring a standing bloodpressure. The method may include determining that the patient is in astanding position. The method may include measuring a standing bloodpressure of the patient when the patient in the standing position. Themethod may include comparing the supine blood pressure to die standingblood pressure to determine whether the hypertension in the patient isorthostatic. The method may include determining that the hypertension inthe patient is orthostatic based on the comparison. The method mayinclude applying the renal denervation energy to the patient based onthe hypertension in die patient being orthostatic and a treatment modelso that the application of the renal denervation energy may be tailoredto the patient.

The method may include predicting an effectiveness or a responsivenessof the application of the renal denervation energy to the patient. Theprediction may be based on a treatment model and may be done prior toapplying the renal denervation energy to die patient.

In another aspect, the subject matter is embodied in a therapeuticassembly for renal denervation. The therapeutic assembly includes anenergy delivery element. The energy delivery element is configured toprovide renal denervation energy to a nerve within a blood vessel of apatient. The therapeutic assembly includes a controller. The controlleris coupled to the energy delivery element. The controller is configuredto determine that the hypertension in the patient is orthostatic. Thecontroller is configured to apply renal denervation energy to thepatient using the energy delivery element.

In another aspect, the subject matter is embodied in a method fortreatment of hypertension in a patient. The method includes measuring asupine blood pressure of the patient when the patient is in a supineposition. The method includes measuring a standing blood pressure of thepatient when the patient in a standing position. The method includescomparing the supine blood pressure to the standing blood pressure. Themethod includes determining that the hypertension in the patient isorthostatic based on the comparison. The method includes predicting aneffectiveness or a responsiveness of renal denervation therapy to thepatient. The method includes providing the predicted effectiveness ordie predicted responsiveness to an operator.

BRIEF DESCRIPTION OF THE DRAWINGS

Other systems, methods, features, and advantages of the presentinvention will be or will become apparent to one of ordinary skill inthe art upon examination of the following figures and detaileddescription. It is intended that all such additional systems, methods,features, and advantages be included within this description, be withinthe scope of the present invention, and be protected by the accompanyingclaims. Component parts shown in the drawings are not necessarily toscale and may be exaggerated to better illustrate the important featuresof the present invention. In the drawings, like reference numeralsdesignate like parts throughout the different views.

FIG. 1 shows an example conceptual illustration of the therapeuticassembly according to an aspect of the invention.

FIG. 2A shows an example renal denervation device of the therapeuticassembly of FIG. 1 in a low-profile delivery configuration according toan aspect of the invention.

FIG. 2B shows an example renal denervation device of the therapeuticassembly of FIG. 1 in an expanded deployed configuration according to anaspect of the invention.

FIG. 3 shows an example renal denervation device of the therapeuticassembly of FIG. 1 in the expanded deployed configuration within a bloodvessel according to an aspect of the invention.

FIG. 4 is a block diagram of an example generator of the therapeuticassembly of FIG. 1 according to an aspect of the invention.

FIG. 5 is a flow diagram of an example process for controlling theenergy delivered to the one or more energy delivery elements of thetherapeutic assembly of FIG. 1 according to an aspect of the invention.

FIG. 6 is a flow diagram of an example process for determining the bloodpressure of the human patient using the therapeutic assembly of FIG. 1according to an aspect of the invention.

FIG. 7 is a flow diagram of an example process for comparing the bloodpressure of the human patient when in the standing position and in thesupine position to determine whether the hypertension is orthostaticusing the therapeutic assembly of FIG. 1 according to an aspect of theinvention.

FIG. 8 is a bar chart that shows an example of blood pressure responseto renal denervation to off-med patients at 3 months over 24 hours undera first definition of orthostatic hypertension using the therapeuticassembly of FIG. 1 according to an aspect of the invention.

FIG. 9 is a bar chart that shows an example of blood pressure responseto renal denervation to off-med patients at 3 months in the morningunder a first definition of orthostatic hypertension using thetherapeutic assembly of FIG. 1 according to an aspect of the invention.

FIG. 10 is a bar chart that show's an example of blood pressure responseto renal denervation to off-med patients at 3 months in the peak morningunder a first definition of orthostatic hypertension using thetherapeutic assembly of FIG. 1 according to an aspect of the invention.

FIG. 11 is a bar chart that shows an example of blood pressure responseto renal denervation to off-med patients at 3 months in the nighttimeunder a first definition of orthostatic hypertension using dietherapeutic assembly of FIG. 1 according to an aspect of the invention.

FIG. 12 is a bar chart that shows an example of blood pressure responseto renal denervation to off-med patients in the daytime under a firstdefinition of orthostatic hypertension using the therapeutic assembly ofFIG. 1 according to an aspect of the invention.

FIG. 13 is tabular presentation of statistical analysis of interactionsbetween treatment and orthostatic hypertension under the firstdefinition of orthostatic hypertension using the therapeutic assembly ofFIG. 1 according to an aspect of the invention.

FIG. 14 is a table summarizing example blood pressure responses forpatients that received RDN under the first definition of orthostatichypertension using the therapeutic assembly of FIG. 1 according to anaspect of the invention.

FIG. 15 is a bar chart that shows an example of blood pressure responseto renal denervation to off-med patients at 3 months over 24 hours undera second definition of orthostatic hypertension using the therapeuticassembly of FIG. 1 according to an aspect of the invention.

FIG. 16 is a bar chart that shows an example of blood pressure responseto renal denervation to off-med patients at 3 months in the morningunder a second definition of orthostatic hypertension using thetherapeutic assembly of FIG. 1 according to an aspect of the invention.

FIG. 17 is a bar chart that shows an example of blood pressure responseto renal denervation to off-med patients at 3 months in the peak morningunder a second definition of orthostatic hypertension using thetherapeutic assembly of FIG. 1 according to an aspect of the invention.

FIG. 18 is a bar chart that shows an example of blood pressure responseto renal denervation to off-med patients at 3 months in the nighttimeunder a second definition of orthostatic hypertension using thetherapeutic assembly of FIG. 1 according to an aspect of the invention.

FIG. 19 is a bar chart that show's mi example of blood pressure responseto renal denervation to off-med patients in the daytime under a seconddefinition of orthostatic hypertension using the therapeutic assembly ofFIG. 1 according to an aspect of the invention.

FIG. 20 is tabular presentation of statistical analysis of interactionsbetween treatment and orthostatic hypertension under the seconddefinition of orthostatic hypertension using the therapeutic assembly ofFIG. 1 according to an aspect of the invention.

FIG. 21 is a table summarizing example blood pressure responses forpatients that received RDM under the second definition of orthostatichypertension using the therapeutic assembly of FIG. 1 according to anaspect of the invention.

DETAILED DESCRIPTION

Disclosed herein are systems, devices, methods and/or apparatuses todetect or determine the effectiveness or the responsiveness of renaldenervation therapy on hypertensive patients. In an analysis of renaldenervation in patients with uncontrolled hypertension in the absence ofantihypertensive medications it was revealed that renal denervation ismore likely to be effective in patients with orthostatic hypertensionthan in patients without orthostatic hypertension, and so, thetherapeutic assembly determines the type of hypertension to betterunderstand the predicted effectiveness or responsiveness to the renaldenervation therapy.

The therapeutic assembly determines whether hypertension within apatient is orthostatic and is able to predict the effectiveness or theresponsiveness of the renal denervation therapy on the patient. Thetherapeutic assembly may use u treatment model to predict theeffectiveness or the responsiveness of the renal denervation therapy onthe patient, which allows an operator, such as a doctor, nurse or otherhealthcare professional to better assess the risks and likely outcomesof the renal denervation therapy to the specific patient. This minimizesdie application or use of ineffective procedures and allows for theoperator to anticipate any necessary follow-up treatments or procedures.

Other benefits and advantages include the capability to determine themost effective application of the renal denervation energy to treat acondition. The therapeutic assembly may use the analysis of theeffectiveness or responsiveness of the patient to renal denervationtherapy to determine an amount of renal denervation energy to deliver, afrequency of delivery for the renal denervation energy over a period oftime and/or the number of times that the renal denervation energy shouldbe applied. The therapeutic assembly may automatically control thedelivery of die renal denervation energy based on the determined courseof treatment and apply the renal denervation energy to the nerves withinthe wall of the blood vessel to attain the desired result, such as diemitigation of a symptom, a biological parameter, such as blood pressure,or a condition of a disease.

FIG. 1 shows the therapeutic assembly 100. The therapeutic assembly 100performs renal denervation within the renal artery of a human patient.Renal denervation is a minimally invasive procedure to treathypertension. The therapeutic assembly 100 may perform the renaldenervation endovascularly, intravascularly or externally from the humanpatient. For example, the therapeutic assembly 100 may be a transducerpositioned external to the human patient to deliver ultrasound energyinto the body of the human patient. In another example, the therapeuticassembly 100 may be include a catheter or other device that is insertedinto the human patient, such as via a small incision.

The therapeutic assembly 100 includes a renal denervation device 102and/or a generator 104. The therapeutic assembly 100 may include or becoupled to one or more sensors 103, such as a sphygmomanometer, bloodpressure gauge or blood pressure monitor 103 a, which may be used tomeasure the blood pressure of the human patient. The one or more sensors103 that measure the blood pressure of the human patient may measure thesystolic blood pressure (SBP) and/or the diastolic blood pressure (DBP).The SBP and/or the DBP may be measured when the human patient is in thesupine position and/or the standing position. The one or more sensors103 may include a camera 103 b or other position sensor. The positionsensor may be a sensor that detects a position of the human patient,such as when the human patient is lying down, e.g., in a supineposition, and or standing up. e.g., in a standing position. The camera103 b may capture image data of the human patient, which a processor,such as the controller within the generator 104 may analyze to determinethe position of the human patient. The one or more sensors 103 may beintegrated within, coupled to or otherwise connected to the generator104.

The renal denervation device 102 may include any device that deliversenergy or stimulus to a target nerve within a wall of a blood vessel,such as the renal nerve of the renal artery. The device that deliversthe energy or stimulus to the target nerve may be positioned external tothe human patient, such as a transducer that emits ultrasound energy, ormay be intravascularly positioned within the blood vessel to deliver theenergy or stimulus, such as the renal denervation device 102. The energyor stimulus may include, for example, at least one of a radio frequencystimulus, a thermal stimulus, a cryogenic stimulus, a microwavestimulus, an ultrasonic or ultrasound stimulus or other form of energyor stimulus. Regardless of the type of energy delivered, the renaldenervation device 102 does nor fully occlude die blood vessel, andthus, blood may continue to flow through the blood vessel.

The renal denervation device 102 may have a catheter 108 and/or one ormore energy delivery elements 110, such as an electrode, and/or one ormore sensors 112, such as a temperature sensor, blood flow sensor,impedance sensor or other sensor to interpolate characteristics of theheart rate, blood flow, blood pressure or other parameter. The renaldenervation device 102 may have an elongated shaft 14 with a handle 116.The elongated shad 114 with the handle 116 may be used to guide and/oradvance a distal portion of the catheter 108 through the blood vesselsof the patient, such as a human patient, to a target location of a bloodvessel and remotely manipulate the distal portion of the catheter 108.The catheter 108 may be intravascularly delivered into the patient,e.g., a blood vessel of the patient, in a low-profile configuration,such as the substantially straight configuration shown in FIGS. 1 and2A. The catheter 108 may be over a meter in length. Upon delivery to atarget location within and along the blood vessel, the catheter 108 maybe deployed into an expanded deployed configuration, such as a generallyhelical or spiral configuration or other suitable configuration, whichthe one or more energy delivery elements 110, such as one or moreelectrodes, may contact the blood vessel, as shown in FIG. 3 forexample. In the expanded deployed stale, the renal denervation device102 may deliver energy at a treatment site and providetherapeutically-effective electrical and/or thermally induceddenervation to a nerve within the wall of the blood vessel. FIGS. 2A-2Bshow the deployment of the renal denervation device 102. In particular.FIG. 2A shows the catheter 108 in the low-profile configuration, andFIG. 2B shows the catheter 108 in the expanded deployed configuration.

The catheter 108 may have a distal tip 202. The distal tip 202 pointsinto the lumen of the blood vessel. The distal tip 202 may have a highdensity marker baud 204. The high density marker band 204 allows aclinician to identity the distal lip 202 of the catheter 108 underfluoroscopy. The distal tip 202 may be approximately 4 cm-5 cm inlength.

The catheter 108 may have a wire 206 within the lumen of the catheter108. The distal tip 202 allows the wire 206 to extend out and away fromthe distal tip 202 when the catheter 108 is in the low-profileconfiguration and to be advanced through the blood vessels to the targetlocation of the blood vessel. When the wire 206 is retracted within thedistal tip 202 and into the catheter 108, the catheter 108 changes shapefrom the low-profile configuration, such as the substantially straightconfiguration, as shown in FIG. 2A for example, to live expandeddeployed configuration, such as a generally helical or spiralconfiguration, as shown in FIG. 2B for example.

The renal denervation device 102 has one or more energy deliveryelements 110. The one or more energy delivery elements 110 may includean electrode, such as a radiofrequency electrode, a radiofrequencyprobe, a thermal probe, a cryogenic probe, a microwave probe, anultrasonic probe, an optical source or a chemical injector. The one ormore energy delivery elements 110 may be positioned on the distalportion of the catheter 108. The one or more energy delivery elements110 may include multiple energy delivery elements 110, such as theenergy delivery elements 1110 a-d, as shown in FIGS. 2A, 2B and 3 forexample. The energy delivery elements 110 a-d may be arrangedapproximately 90 degrees apart relative to a longitudinal axis that runsthrough the center of the catheter 108 when in the spiral configuration.The energy delivery elements 110 may be spaced any suitable distancefrom each other, and the spacing may vary based on the application ofthe therapeutic assembly 100 and its intended use.

When there are multiple energy delivery elements 110, each energydelivery element 110 may deliver power independently, eithersimultaneously, selectively, and/or sequentially, to a treatment site.The multiple energy delivery elements 110 may deliver power among anydesired combination of the one or more energy delivery elements 110. Themultiple energy delivery elements 110 may include any number of energydelivery elements 110.

The one or more energy delivery elements 110 may be introduced into andadvanced along a blood vessel 304, such as the renal artery and may bepositioned to contact the blood vessel 304 in the expanded deployedconfiguration at different intervals and or locations along the wall ofthe blood vessel 304. For example, a first energy delivery element 110 amay contact the wall of the blood vessel 304 at a first location 302 a,a second energy delivery element 110 b may contact the wall of the bloodvessel 304 at a second location 302 b, a third energy delivery element110 c may contact the wall of the blood vessel 304 at a third location302 c and a fourth energy delivery element 110 d may contact the wall ofthe blood vessel 304 at a fourth location 302 d. The renal denervationdevice 102 may deliver energy through the one or more energy deliveryelements 110 at the treatment site and provide therapeutically-effectiveelectrically- and/or thermally-induced denervation.

The renal denervation device 102 may include one or more sensors 112.The one or more sensors 112 may be a sensor that measures a parameter,such as temperature, impedance, blood pressure, optical, blood flow, oramount of chemical. The one or more sensors 112 may be proximate to orwithin the energy delivery element 110. The measured parameter may beused to interpolate another parameter. For example, measured temperaturemay be used to interpolate the heart rate of the patient.

Each of the one or more sensors 112 may be coupled to, integrated withor in a close proximity to a corresponding one of the one or more energydelivery elements 110. This allows each of the one or more sensors 112to measure the parameter local to the energy delivery element 110 sothat the parameter reflects to the effects of the energy deliveryelement 110 on the location tissue. For example, the first sensor 112 amay be integrated with the first energy delivery element 110 a, thesecond sensor 112 b may be integrated with second energy deliveryelement 110 b, the third sensor 112 c may be integrated with the thirdenergy delivery element 110 c and the fourth sensor 112 d may beintegrated with the fourth energy delivery element 110 d, as shown inFIG. 2B for example.

For example, the energy delivery element 110 may be an electrode, whichhas two wires. One wire may be made from copper and the other may bemade from a copper-nickel allow. The wires may both transmit the signalfrom the sensor 112 and also convey the energy to the energy deliveryelement. The signal may be a temperature signal that indicates thetemperature of the blood vessel, a pressure signal that indicates theblood flow or pressure near the location targeted by the electrode.

The therapeutic assembly includes a generator 104. The generator 104 maybe a radio frequency generator or other generator that delivers adenervation stimulus or energy through the one or more energy deliveryelements 110 to the wall of the blood vessel at the treatment location.The denervation stimulus may include a non-electric stimulus, forexample, a chemical agent, optical stimulus, a thermal stimulus, acooling stimulus, a microwave stimulus or other form of stimuli. Thegenerator 104 may have a cable, an electrical lead and or wire that iselectrically conductive and runs through the catheter 108 within a lumenand is electrically coupled with the one or more energy deliveryelements 110. In some implementations, the generator 104 may haveseparate leads and/or wires that electrically couple with acorresponding energy delivery element 110 of the one or more energydelivery elements 110 so that each energy delivery element 110 mayoperate independently of the others. For example, the generator 104 mayhave multiple separate channels, such as four RF channels to deliver RFenergy independently to the energy delivery elements 110 a-d and controland monitor each energy delivery element 110 a-d independently. Thegenerator 104 may generate energy that ultimately is transmitted throughthe electrical lead to the one or more energy delivery elements 110.

The generator 104 may have one or more processors 402, a memory 404, auser interface 118, a network access device 410 and or a power source408, as shown in FIG. 4 for example. The one or more processors 402 maybe electrically coupled to the memory 404, the user interlace 118 and/orthe power source 408. The one or more processors 402 may include one ormore controllers that measure the blood pressure of the human patient,formulate or predict the effectiveness or responsiveness of renaldenervation therapy on the human patient and/or formulate and administera course of treatment for the delivery of the renal denervation energy.

The one or more processors 402 may control a state of each of the one ormore energy delivery elements 110 and the amount of energy delivered toeach of the one or more energy delivery elements 110 by the power source408 to manage the course and administration of treatment at thetreatment site. The one or more processors may be coupled to the memory404 and execute instructions that are stored in the memory 404.

The generator 104 may have a memory 404. The memory may be coupled tothe one or more processors 402 and store instructions that the one ormore processors 402 executes. The memory 404 may include one or more ofa Random Access Memory (RAM), Read Only Memory (ROM) or other volatileor non-volatile memory. The memory 404 may be a non-transitory memory ora data storage device, such as a hard disk drive, a solid-state diskdrive, a hybrid disk drive, or other appropriate data storage, and mayfurther store machine-readable instructions, which may be loaded andexecuted by the one or more processors 402. The memory 404 may store oneor more thresholds for the determination of whether the hypertension ofthe human patient is orthostatic or not, which may affect the predictedeffectiveness or responsiveness of renal denervation therapy and/or thecourse of treatment for the delivery of the renal denervation energy tothe human patient.

The generator 104 may have a power source 408, such as a RF generator orother electrical source. The power source 408 provides a selected formand magnitude of energy for delivery to the treatment site via the renaldenervation device 102. The generator 104 may have a user interface 118.Tire generator 104 may receive input, such as the selected form and themagnitude of energy to be delivered to each of the one or more energydelivery elements 110, via the user interface 118. The user interface118 may receive other user input including the blood pressure of thehuman patient and/or the position of the human patient, such as when thehuman patient is in the supine position or the standing position.

The user interface 118 may include an input output device that receivesuser input from a user interface element, a button, a dial, amicrophone, a keyboard, or a touch screen. The user interface 118 mayprovide an output to an output device, such as a display, a speaker, anaudio and/or visual indicator, or a refreshable braille display. Theoutput device may display an alert or notification or other informationto the clinician and or to confirm status and or commands from theclinician. The output device may be an audio output device that outputsan audio indicator that indicates the notification or information to beprovided to the clinician.

In some implementations, the camera 103 b or other position sensor maybe included within the generator 104. The camera 103 b or other positionsensor may be used to capture data, such as image data, to determine theposition of the human patient, such as whether the human patient is inthe supine position or the standing position.

The network access device 410 may include a communication port orchannel, such as one or more of a Dedicated Short-Range Communication(DSRC) unit, a Wi-Fi unit, a Bluetooth® unit, a radio frequencyidentification (RFID) tag or reader, or a cellular network unit foraccessing a cellular network (such as 3G, 4G or 5G). The network accessdevice 410 may transmit data to and receive data from an externaldatabase or remote server.

FIG. 5 is a How diagram of a process 500 for controlling the energydelivered to the one or more energy delivery elements 110. One or morecomputers or one or more data processing apparatuses, for example, theprocessor 402 of the generator 104 of the therapeutic assembly 100 ofFIG. 1 , appropriately programmed, may implement the process 500.

The therapeutic assembly 100 includes a generator 104, which controlsthe delivery of energy to the one or more energy delivery elements 110of the renal denervation device 102. The therapeutic assembly 100 mayreceive or obtain a treatment model (502). The treatment model may bebased on an accumulation of population patient data that corresponds tovarious characteristics or parameters of a human patient, varioustreatments, various disease conditions and/or the corresponding and/orresulting effectiveness and/or responsiveness of the delivered energyfor each of the disease conditions when following the correspondingtreatment. The treatment model may be generated from population patientdata that is generated in real-time along with experimental data fromclinical trials, such as the experimental data presented in FIGS. 8-21 ,to identify the effectiveness and/or responsiveness of the renaldenervation on patients with hypertension that is or is not orthostatic.

The characteristics or parameters of the human patient may includedemographic data, age, sex, body mass index (BMI), blood pressurevalues, cholesterol level, activity level, sleeping habits and/or othercharacteristics or parameters of the human patient. The varioustreatments may be associated with the amount of energy delivered, thefrequency of the amount of energy delivered over a period of time, thelength of the period of time of the continued delivery of the energyand/or the location and/or treatment site where the energy is delivered.The disease conditions may include various diseases, such as a heartcondition or disease, a gastrointestinal condition or disease, animmunological or respiratory condition or disease and/or other conditionor disease. The effectiveness and/or responsiveness of the deliveredenergy for each of the disease conditions may include a likelihoodand/or an amount of improvement of a parameter associated or related tothe disease or condition, such as a decrease in blood pressure ofapproximately 10%-15% or a decrease in the likelihood of a heartcondition of approximately 10%-15%. The treatment model relates or mapseach of these factors with the other factors so that the treatment modelmay be used to anticipate or predict that a human patient with aspecific set of characteristics or parameters, such as particular bodyweight, height, level of activity or other characteristics orparameters, when given a particular course of treatment, such as anablation once a month for a couple months, will likely result in a giveneffectiveness and/or responsiveness to the disease or condition, such asa decrease in the likelihood of a heart condition.

The therapeutic assembly 100 may obtain the treatment model via userinput through the user interface 118. In some implementations, thetherapeutic assembly may obtain the treatment model from an externaldatabase or a remote server via the network access device 410.

The therapeutic assembly 100 may determine that the hypertension in ahuman patient is orthostatic (504). The therapeutic assembly 100 maycollect or obtain sensor data and/or user input to determine whether thehypertension in the patient is orthostatic. If the hypertension isorthostatic, the delivery of the energy may be more effective intreating the disease or condition of the patient. And if thehypertension is not orthostatic, the delivery of the energy may be lesseffective than when the hypertension is orthostatic. FIGS. 6-7 furtherdescribe the process for determining whether the hypertension in thehuman patient is or is not orthostatic.

The therapeutic assembly 100 may predict the effectiveness orresponsiveness to application of the renal denervation energy (506). Theeffectiveness or the responsiveness may be based on whether thehypertension is orthostatic or not. A patient with hypertension that isorthostatic may be more responsive to the application of the renaldenervation energy, and so, the therapeutic assembly 100 may account forwhether the hypertension is orthostatic or not when determining theeffectiveness or the responsiveness.

The therapeutic assembly 100 may use the treatment model to predict theeffectiveness or responsiveness to the application of the renaldenervation energy prior to applying the renal denervation energy to atreatment site. The effectiveness or responsiveness may be a measure, aprobability and/or a likelihood that the renal denervation energy mayimprove a disease or condition.

The improvement of the disease or condition may be determined by anamount of change or improvement in a parameter associated with thedisease or condition, such as a decrease in blood pressure, a decreasein cholesterol and/or other parameter when relating to a heart disease,for example. The improvement of the disease or condition may bedetermined by the elimination or reduction in a symptom caused by thedisease or condition, or the elimination or reduction in a measurablequantity of the disease or condition within the human patient, asdetermined by a doctor, nurse or other health care professional whoprovides the qualitative or quantitative success, partial success orfailure in the elimination or reduction in the symptom, condition and/ordisease. The probability and/or the likelihood may be quantified as apercentage of success or a percentage of failure that represents theoverall improvement of the condition or disease relative tonon-treatment or non-use of renal denervation energy to innervate thetreatment site. As shown in FIGS. 8-21 below, the improvement in thesymptom, condition and/or disease is greater in patients withhypertension that is orthostatic.

The therapeutic assembly 100 may provide the effectiveness or theresponsiveness to the delivery of the renal denervation energy to aclinician, such as a doctor, nurse or other health care professional(508). The therapeutic assembly 100 may display the effectiveness or theresponsiveness on the user interface 118, such as on the display, topresent to the clinician the effectiveness or the responsiveness to thedelivery of the renal denervation energy. When providing theeffectiveness or the responsiveness, the therapeutic assembly 100 mayindicate the likelihood or probability of success, partial success,and/or failure and or the predicted resulting state of the disease orcondition after delivery of the renal denervation energy. This allowsthe operator to analyze and review the anticipated outcome of theapplication of the renal denervation energy before the human patientundergoes renal denervation therapy.

In some implementations, the therapeutic assembly 100 may simultaneouslyrequest confirmation that the clinician would like the therapeuticassembly 100 to proceed with applying renal denervation energy to thetreatment site when providing the effectiveness or responsiveness to therenal denervation energy. This allows the clinician to weigh the costsand benefits of the application of the renal denervation energy andinform the human patient of the predicted consequences of theapplication of the renal denervation energy.

The therapeutic assembly 100 may obtain user input (510). Thetherapeutic assembly 100 may obtain user input that indicates orconfirms that the clinician desires to apply the renal denervationenergy to the treatment site. The user input may be received via theuser interface 118. This allows the clinician to confirm that thetherapeutic assembly 100 should proceed with renal denervation therapy.

The therapeutic assembly 100 may determine the course of treatmentincluding the number of times, amount and/or frequency of delivery ofdie renal denervation energy to the treatment site (512). The course oftreatment may also indicate a treatment site or location of which therenal denervation energy should be applied or delivered. The treatmentstrategy, such as the aggressiveness of the course of treatment, may beaffected by whether the hypertension is determined to be orthostatic ornot orthostatic.

The number of times may indicate the number of different times that thehuman patient must receive the course of treatment to achieve thepredicted effectiveness and or responsiveness to the renal denervationenergy for the condition or disease of the human patient. The amount mayindicate the magnitude of the amount of renal denervation energydelivered for each time that the renal denervation energy is applied oris delivered to the human patient. The frequency may indicate the numberof times within each period of time and the number of periods of time ofwhich the renal denervation energy should be applied or delivered to thehuman patient for the course of treatment, such as once a week for aperiod of 3 months.

The therapeutic assembly 100 may determine the course of treatment usingthe treatment model and the specific characteristics, features andparameters of the human patient. The therapeutic assembly 100 maycompare the specific characteristics, features and parameters of thehuman patient and identity similar patients within the treatment modelwith those same or corresponding specific characteristics, features andparameters to identify the course of treatment that provides thegreatest likelihood or probability of success for the condition ordisease. The treatment model allows the therapeutic assembly 100 totailor the course of treatment to the specific human patient, whichincreases the chance of success for the individual.

Once the course of treatment is generated, the therapeutic assembly 100delivers or applies the renal denervation energy to the treatment site(514). The therapeutic assembly 100 may use the generator 104 togenerate energy or stimuli to deliver through the one or more energydelivery elements 110 at the treatment site. In some implementations,the therapeutic assembly 100 may identify that the one or more energydelivery elements 110 are positioned at the treatment site prior to thedelivery of the energy or stimuli. The therapeutic assembly 100 maydeliver or apply the renal denervation energy to the treatment site onlywhen the user has confirmed that the application of the renaldenervation energy is to proceed or may delivery or apply the renaldenervation energy automatically.

FIG. 6 is a flow diagram of a process 600 for determining the bloodpressure of the human patient. One or more computers or one or more dataprocessing apparatuses, for example, the processor 402 of the generator104 of the therapeutic assembly 100 of FIG. 1 , appropriatelyprogrammed, may implement the process 600.

The therapeutic assembly 100 may determine or detect a position of thehuman patient (602). The therapeutic assembly 100 may use one or moresensors 103, such as the camera 103 b, to determine or detect theposition of the human patient. For example, the camera 103 b may captureimage data of the human patient and analyze the human patient todetermine the position of the human patient, such as the orientation ofthe human patient. The therapeutic assembly 100 may use the orientationof the human patient to determine whether the human patient is in astanding or supine position. In another example, the therapeuticassembly 100 may have one or more sensors 103 coupled to the body of thehuman patient, which assists die therapeutic assembly 100 in determiningthe position, such as the orientation, of the human patient to determinewhether the human patient is in a standing or supine position.

The therapeutic assembly 100 determines that the human patient is in thesupine position (604). The therapeutic assembly 100 may determine thatthe human patient is in die supine position based on the orientation ofthe human patient relative to a planar surface, such as the floor. Thetherapeutic assembly 100 may analyze the image data and recognize thehuman patient and the planar surface, such as the floor, by comparingthe outline or skeleton of the human patient and the planar surface to alibrary of objects to identify tire human patient and the planarsurface. Once recognized, the position including the orientation of thehuman patient may be compared to the planar surface to determine whetherthe human patient is parallel to the planar surface, and when the humanpatient is parallel to the planar surface, the therapeutic assembly 100may determine that the human patient is in the supine or lying position.

In some implementations, the therapeutic assembly 100 may receive userinput, such as from the clinician, to determine that the human patientis in the supine position. The therapeutic assembly 100 may receive theuser input via the user interface 118. The user input may indicate theposition including the orientation of the human patient, such as whetherdie human patient is in the supine, standing or other position. Thetherapeutic assembly 100 may determine that the human patient is in thesupine position when the user input indicates that the human patient isin the supine position.

Once the human patient is determined to be in the supine position, thetherapeutic assembly 100 may measure, obtain or otherwise determine thesupine blood pressure of the human patient (606). The supine bloodpressure is the blood pressure of the human patient while the humanpatient is in the supine position. The supine blood pressure includesthe systolic blood pressure (SBP) and the diastolic blood pressure (DBP)when the human patient is in the supine or lying position. Thetherapeutic assembly 100 may use one or more sensors 103, such as theblood pressure monitor 103 a, to obtain the supine blood pressure. Theblood pressure monitor may be coupled or connected to the human patientwhile the human patient is in the supine position to measure the supineblood pressure of the human patient while the human patient is in thesupine position. In some implementations, the therapeutic assembly 100may receive or obtain the supine blood pressure via user input on theuser interface 118 that indicates the supine blood pressure. Forexample, the clinician may use the blood pressure monitor 103 a tomeasure the supine blood pressure and input the supine blood pressureinto therapeutic assembly 100 via the user interface 118.

After the supine blood pressure Is measured and determined, thetherapeutic assembly 100 may wait or delay a period of time before thetherapeutic assembly 100 attempts to measure the standing blood pressure(608). The period of lime may be approximately 5-10 minutes to allow diephysiological parameters of human patient to transition from the supineposition to a standing position. The period of time may beuser-configured, user-inputted or pre-determined. In someimplementations, the therapeutic assembly 100 may request a userconfirmation before proceeding with determining the standing bloodpressure. The therapeutic assembly 100 may proceed with determining thestanding blood pressure after receiving the user confirmation.

After the period of time, the therapeutic assembly 100 repeatsdetermining or detecting the position of die human patient, as describedabove (610). Then, the therapeutic assembly 100 determines that thehuman patient is in the standing position (612). The therapeuticassembly 100 may determine that the human patient is in the standingposition based cm the orientation of the human patient relative to aplanar surface, such as die floor. Similar to detecting the supineposition, the therapeutic assembly 100 may analyze the image data andrecognize the human patient and the planar surface, such as the floor,by comparing the outline or skeleton of the human patient and the planarsurface to a library of objects to identify the human patient and theplanar surface. However, once recognized, the position including theorientation of the human patient may be compared to the planar surfaceto determine whether the human patient is perpendicular to the planarsurface, and when the human patient is perpendicular to the planarsurface, the therapeutic assembly 100 may determine that the humanpatient is in the standing position.

In some implementations, the therapeutic assembly 100 may receive userinput, such as from the clinician, to determine that the human patientis in the standing position. Hie therapeutic assembly 100 may receivethe user input via the user interface 118. The user input may indicatethe position including the orientation of the human patient, such aswhether the human patient is in the supine, standing or other position.The therapeutic assembly 100 may determine that the human patient is inthe standing position when the user input indicates that the humanpatient is in the standing position.

Once the human patient is determined to be in the standing position, thetherapeutic assembly 100 may measure, obtain or otherwise determine thestanding blood pressure of the human patient (614). The standing bloodpressure is the blood pressure of the human patient while the humanpatient is in the standing position. The standing blood pressureincludes the systolic blood pressure (SBP) and the diastolic bloodpressure (DBP) when the human patient is in the standing position. Thetherapeutic assembly 100 may use one or more sensors 103, such as theblood pressure monitor 103 a, to obtain the standing blood pressure. Theblood pressure monitor may be coupled or connected to the human patientwhile the human patient is in the standing position to measure thestanding blood pressure of the human patient while the human patient isin the standing position. In some implementations, the therapeuticassembly 100 may receive or obtain the standing blood pressure via userinput on the user interface 118 that indicates the standing bloodpressure. For example, the clinician may use the blood pressure monitor103 a to measure the standing blood pressure and input the standingblood pressure into therapeutic assembly 100 via the user interface 118.

Alter the standing blood pressure and the supine blood pressure aremeasured, obtained or otherwise determined, the therapeutic assembly 100may compare the supine and the standing blood pressure (616). Thetherapeutic assembly 100 may compare the supine systolic blood pressureto the standing systolic blood pressure and/or the supine diastolicblood pressure to the standing diastolic blood pressure. The therapeuticassembly 100 may use the comparison to determine whether diehypertension in the patient is orthostatic. FIG. 7 further describes thecomparison of the blood pressures to determine whether the hypertensionin the patient is orthostatic. In some implementations, a clinicianperforms the comparison of the standing blood pressure and the supineblood pressure and determines whether the hypertension in the patient isorthostatic and or whether the patient is a good candidate for renaldenervation after measuring the supine and standing blood pressures.

FIG. 7 is a flow diagram of a process 700 for comparing the bloodpressure of the human patient when in the standing position and in thesupine position to determine whether the hypertension is orthostatic.One or more computers or one or more data processing apparatuses, forexample, the processor 402 of the generator 104 of the therapeuticassembly 100 of FIG. 1 , appropriately programmed, may implement theprocess 700. When determining whether the hypertension is orthostatic,the orthostatic or postural hypertension may be defined in twoalternatives. The first definition of orthostatic hypertension requiresa patient's baseline standing systolic blood pressure (SBP) to begreater than baseline supine SBP by 20 mmHG or more, or a patient'sbaseline standing diastolic blood pressure (DBP) to be greater than abaseline supine DBP by 20 mmHg or more. The second definition oforthostatic hypertension requires a patient's baseline standing systolicblood pressure (DBP) to be greater than a baseline supine SBP by 10 MMHGor more, or a patient's baseline standing diastolic blood pressure (DBP)to be greater than a baseline supine DBP by 10 mmHG or more. Thetherapeutic assembly may implement the two definitions 100, as describedbelow, to determine whether a patient has orthostatic hypertension.

When the therapeutic assembly 100 compares the standing and supine bloodpressures, the therapeutic assembly 100 may compare the diastolic bloodpressures and/or the systolic blood pressures of the human patient whilestanding and while lying down to determine whether the hypertension isorthostatic. The therapeutic assembly 100 determines whether thestanding systolic blood pressure (SBP) is greater than a first thresholdamount (702). The first threshold amount may be an amount that is atleast 10 mmHG greater than the supine SBP, as defined by the seconddefinition, or an amount that is at least 20 mmHG greater than thesupine SBP, as defined by the first definition.

When the standing SBP is greater than the first threshold amount, dietherapeutic assembly 100 may determine that the hypertension isorthostatic (708). The therapeutic assembly 100 may determine that thehypertension is orthostatic when the amount is at least 10 mmHG greaterthan the supine SBP, as defined by the second definition, or when theamount is at least 20 mmHG greater than the supine SBP, as defined bythe first definition.

Otherwise, when the standing SBP is less than or equal to the firstthreshold amount, the therapeutic assembly 100 determines whether thestanding diastolic blood pressure (DBP) is greater than a secondthreshold amount (704). The second threshold amount may be an amountthat is at least 10 mmHG greater than the supine DBP, as defined in thesecond definition, or an amount that is at least 20 mmHG greater thanthe supine DBP, as defined by the first definition.

When die standing DBP is greater than the second threshold amount, thetherapeutic assembly 100 determines that the hypertension is orthostatic(708). The therapeutic assembly 100 may determine that the hypertensionis orthostatic when the amount is at least 10 mmHG greater than thesupine DBP, as defined by the second definition, or when the amount isat least 20 mmHG greater than the supine DBP, as defined by the firstdefinition.

Otherwise, the therapeutic assembly 100 determines that the hypertensionis not orthostatic when the conditions are not met, as defined by thefirst definition or the second definition that is used to perform thedetermination (706). The determination of whether the hypertension is oris not orthostatic affects the effectiveness and or the responsivenessof the application of renal denervation energy to treat the disease orcondition. The definition that is to be satisfied to determine whetherhypertension is orthostatic or not may be selected via user input to theuser interface 118 and/or may be pre-con figured or user-configured.

FIGS. 8-21 show the experimental analysis of a clinical trial studyingrenal denervation in patients with hypertension. The analysis looked forinteractions between treatment, either RDN or control, and orthostatichypertension for various use cases of blood pressure measures. Theinteraction shows the change in blood pressure in patients withorthostatic hypertension and in patients without orthostatichypertension. The various use cases measured the systolic blood pressureat 3 months for the following time periods using the first and seconddefinitions: 1) over 24 hours. 2) during the daytime (9 a.m. to 9 p.m.average). 3) during nighttime (1 a.m. to 6 p.m. average), 4) during themorning (7 a.m. to 9 a.m. average) and during peak morning (i.e. highest1-hour moving average of at least 3 consecutive SBPs between 6 a.m. and10 a.m.). Then, the analysis compared the response rates between RDNsubjects with and without orthostatic hypertension for the same timeperiods.

FIG. 8 is a bar chart that shows the blood pressure response to renaldenervation to off-med patients at 3 months over 24 hours under a firstdefinition of orthostatic hypertension. The bar chart shows that amongthe number. N, subjects that the subjects that had orthostatichypertension showed a greater change, i.e., decrease in SBP when RDN isperformed in comparison to a control group, over the 24 hour period thanthe subjects that did not have orthostatic hypertension when RDN wasperformed. Thus, RDN was more effective in decreasing the SBP over the24 hour period in patients with orthostatic hypertension.

FIG. 9 is a bar chart that shows the blood pressure response to renaldenervation to off-med patients at 3 months in the morning under a firstdefinition of orthostatic hypertension. Here, the subjects that hadorthostatic hypertension showed a greater change, i.e., decrease in SBPwhen RDN is performed in comparison to a control group, over the morningperiod than the subjects that did not have orthostatic hypertensionwhere RDN was performed. Similarly, the bar chart shows that RDN wasmore effective in decreasing the SBP over the morning period in patientswith orthostatic hypertension.

FIGS. 10-12 show similar results showing the effectiveness of RDN in inpatients with orthostatic hypertension. FIG. 10 shows the blood pressureresponse to renal denervation to off-med patients at 3 months in thepeak morning under a first definition, and FIG. 11 shows response ratesto renal denervation to off-med patients at 3 months in the nighttimeunder a first definition. Also, FIG. 12 shows the blood pressureresponse to renal denervation in off-med patients in the daytime under afirst definition. In FIGS. 10-12 , RDN is demonstrated to be moreeffective in patients with orthostatic hypertension than in patientswith no orthostatic hypertension.

FIG. 13 is a tabular presentation of that summarizes the statisticalanalysis of the interactions between treatment of orthostatichypertension patients and non-orthostatic hypertension patients underthe first definition of orthostatic hypertension. The p-value isreported to identify the probability of obtaining results as extreme asthe observed results of a statistical hypothesis test. A smaller p-valuemeans that there is strong evidence in favor of the existence of astatistical significance in the RDN being more effective in orthostatichypertension patients. A larger p-value means that there is weak or noevidence in favor of the existence of a statistical significance in theRDN being more effective in orthostatic hypertension patients.Generally, a threshold of 0.05 is used to determine the statisticalsignificance, and so, a p-value of less than or equal to 0.05 would showthat there is a statistical significance that was observed and a p-valueof greater than 0.05 would show that there was not a statisticalsignificance. FIG. 14 further summarizes the response rates for patientsthat received RDN under the first definition of orthostatichypertension.

FIGS. 15-19 are bar charts that show the blood pressure response torenal denervation to off-med patients at 3 months under the seconddefinition. FIG. 15 shows the response rates to renal denervation tooff-med patients over 24 hours under a second definition of orthostatichypertension. Similar to FIG. 8 , the bar chart shows that among thenumber. N, subjects that die subjects that had orthostatic hypertensionshowed a greater change, i.e., decrease in SBP when RDN is performed incomparison to a control group, over the 24 hour period than the subjectsthat did not have orthostatic hypertension when RDN was performed. Thus,RDN was more effective in decreasing the SBP over the 24 hour period inpatients with orthostatic hypertension.

Similar to FIG. 9 , FIG. 16 also shows the subjects that had orthostatichypertension showed a greater change, i.e., decrease in SBP when RDN isperformed in comparison to u control group, over the morning period thanthe subjects that did not have orthostatic hypertension when RDN wasperformed. And, FIG. 16 shows that RDN was more effective in decreasingthe SBP over the morning period in patients with orthostatichypertension.

FIGS. 17-19 show the blood pressure responses to renal denervation tooff-med patients at 3 months in the peak morning, in the nighttime andin the daytime, respectively, under the second definition. These resultsdemonstrate that RDN is more effective in patients with orthostatichypertension than in patients with no orthostatic hypertension.

FIG. 20 is a tabular presentation of that summarizes the statisticalanalysis of the interactions between treatment of orthostatichypertension patients and non-orthostatic hypertension patients underthe second definition of orthostatic hypertension, and FIG. 21 is atable summarizing the blood pressure responses for patients thatreceived RDN under the second definition of orthostatic hypertension.Under the second definition, the p-values of the null hypothesis isfurther verified in comparison to the p-value of the null hypothesisunder the first definition. That is, the null hypothesis that RDN ismore effective in orthostatic hypertension patients is further confirmedunder the second definition than under the first definition. Inparticular, the experimental results for the morning, peak morning andnighttime have significant p-values greater than 0.05 under the seconddefinition, and thus, verifying that RDN is more effective inorthostatic hypertension patients during these time periods, liventhough FIGS. 8-21 show the effectiveness or responsiveness of renaldenervation on patients that are off-medication that have hypertensionthat is orthostatic, renal denervation is also more effective onpatients that have hypertension that is orthostatic when the patientsare on one or more medications. The use of renal denervation on patientson one or more medication may reduce the amount or number of medicationsthat the patients are taking.

The blood pressure responses, as shown in FIGS. 8-21 , wereexperimentally taken from an example sample or exploratory group of asmall size of patients. In particular, a significant difference is shownbetween the orthostatic and non-orthostatic hypertension groups in theexperimental data for the blood pressure responses over the 24 hourperiod and during the daytime subgroups. The above analyzed experimentaldata is solely an example of a small sample size of patients, and so,the use of a larger sample size of patients would show a similarsignificant difference across all the subgroups.

Exemplary embodiments of the invention have been disclosed in anillustrative style. Accordingly, the terminology employed throughoutshould be read in a non-limiting manner. Although minor modifications tothe teachings herein will occur to those well versed in the art, itshall be understood that what is intended to be circumscribed within thescope of the patent warranted hereon are all such embodiments thatreasonably (all within the scope of the advancement to the art herebycontributed, and that that scope shall not be restricted, except inlight of the appended claims and their equivalents.

What is claimed is:
 1. A method for treatment of hypertension in apatient, the method comprising: determining that the hypertension in thepatient is orthostatic; and applying renal denervation energy to thepatient based on determining that the hypertension in the patient isorthostatic.
 2. The method of claim 1, wherein determining that thehypertension in the patient is orthostatic includes: measuring abaseline standing systolic blood pressure (SBP) of the patient; andmeasuring a baseline supine SBP of the patient.
 3. The method of claim2, wherein determining that the hypertension in the patient isorthostatic includes: determining that the baseline standing systolicblood pressure (SBP) of the patient is greater than the baseline supineSBP by at least 20 mmHg.
 4. The method of claim 2, wherein determiningthat the hypertension in the patient is orthostatic includes:determining that the baseline standing systolic blood pressure (SBP) ofthe patient is greater than the baseline supine SBP by at least 10 mmHg.5. The method of claim 1, wherein determining that the hypertension inthe patient is orthostatic includes: measuring a baseline standingdiastolic blood pressure (DBP) of the patient; and measuring a baselinesupine DBP of the patient.
 6. The method of claim 5, wherein determiningthat the hypertension in the patient is orthostatic includes:determining that the baseline standing diastolic blood pressure (DBP) ofthe patient is greater than the baseline supine DBP by at least 10 mmHg.7. The method of claim 1, wherein applying renal denervation energy tothe patient based on determining that the hypertension in the patient isorthostatic comprises: determining at least one of a number of ablationsor an amount of energy delivered in each ablation of the number ofablations based on the determination that the hypertension in thepatient is orthostatic; and applying the renal denervation energy to thepatient based on the at least one of the number of ablations or theamount of energy delivered in each ablation.
 8. The method of claim 1,wherein applying the renal denervation energy to the patient includes atleast one of using radio frequency (RF) ablation, chemicals, cryotherapyor ultrasound.
 9. The method of claim 1, wherein determining that thehypertension in the patient is orthostatic comprises: determining thatthe patient is in a supine position; measuring a supine blood pressureof the patient when the patient is in the supine position; waiting aperiod of time before measuring a standing blood pressure; determiningthat the patient is in a standing position; measuring a standing bloodpressure of the patient when the patient in the standing position; andcomparing the supine blood pressure to the standing blood pressure todetermine whether the hypertension in the patient is orthostatic. 10.The method of claim 9, further comprising: predicting an effectivenessor a responsiveness of the application of the renal denervation energyto the patient using a treatment model prior to applying the renaldenervation energy to the patient; and providing the predictedeffectiveness or the predicted responsiveness of the application of therenal denervation energy to an operator.
 11. The method of claim 9,wherein determining that the hypertension in the patient is orthostaticis based on the comparison, applying the renal denervation energy to thepatient is based on the hypertension in the patient being orthostaticand a treatment model so that the application of the renal denervationenergy is tailored to the patient.
 12. The method of claim 1, whereinapplying renal denervation energy to the patient based on determiningthat the hypertension in the patient is orthostatic comprises:determining one or more renal denervation parameters based ondetermining that the hypertension in the patient is orthostatic.
 13. Themethod of claim 12, wherein the one or more renal denervation parameterscomprise at least one of a number of ablations, an amount of energydelivered in each ablation of the number of ablations, or a frequency ofdelivery of energy over a period of time.
 14. A therapeutic assembly forrenal denervation, the therapeutic assembly comprising: an energydelivery element configured to provide renal denervation energy to anerve within a blood vessel of a patient; and a controller configuredto: determine that the hypertension in the patient is orthostatic, andcontrol delivery of renal denervation energy to the patient using theenergy delivery element based on determining that the hypertension inthe patient is orthostatic.
 15. The therapeutic assembly of claim 14,further comprising: a first sensor configured to detect a position ofthe patient; a second sensor configured to detect a blood pressure ofthe patient; wherein, to determine that the hypertension in the patientis orthostatic, the controller is configured to: determine, using thefirst sensor, that the patient is in a supine position based on thedetected position of the patient, determine, using the second sensor, asupine blood pressure of the patient when the patient is in the supineposition based on the detected blood pressure, determine, using thefirst sensor, that the patient is in a standing position based on thedetected position of the patient, determine, using the second sensor, astanding blood pressure of the patient when the patient in the standingposition based on the detected blood pressure; and compare the supineblood pressure to the standing blood pressure to determine whether thehypertension in the patient is orthostatic.
 16. The therapeutic assemblyof claim 15, further comprising: a user interface to provide and receiveinput data or output data; wherein the controller is coupled to the userinterface and configured to: receive user input that indicates astanding blood pressure of the patient and a supine blood pressure ofthe patient, compare the standing blood pressure of the patient to thesupine blood pressure of the patient to determine whether thehypertension in the patient is orthostatic, predict an effectiveness ora responsiveness of application of the renal denervation energy to thepatient using a treatment model prior to applying the renal denervationenergy to the patient and based on the comparison, and render, on theuser interface, the predicted effectiveness or the predictedresponsiveness of the application of the renal denervation energy to anoperator.
 17. The therapeutic assembly of claim 14, wherein to determinethat the hypertension in the patient is orthostatic the controller isconfigured to determine that a baseline standing systolic blood pressureis greater than a baseline supine SBP by at least 10 mmHg or that abaseline standing diastolic blood pressure (DBP) of the patient isgreater than the baseline supine DBP by at least 10 mmHg.
 18. Thetherapeutic assembly of claim 14, wherein determine that thehypertension in the patient is orthostatic the controller is configuredto determine that a baseline standing systolic blood pressure is greaterthan a baseline supine SBP by at least 20 mmHg or that a baselinestanding diastolic blood pressure (DBP) of the patient is greater thanthe baseline supine DBP by at least 20 mmHg.
 19. The therapeuticassembly of claim 14, wherein to control delivery of renal denervationenergy to the patient based on determining that the hypertension in thepatient is orthostatic, the controller is configured to determine one ormore renal denervation parameters based on determining that thehypertension in the patient is orthostatic.
 20. The therapeutic assemblyof claim 19, wherein the one or more renal denervation parameterscomprise at least one of a number of ablations, an amount of energydelivered in each ablation of the number of ablations, or a frequency ofdelivery of energy over a period of time.
 21. A method for treatment ofhypertension in a patient, the method comprising: measuring a supineblood pressure of the patient when the patient is in a supine position;measuring a standing blood pressure of the patient when the patient in astanding position; comparing the supine blood pressure to the standingblood pressure; determining that the hypertension in the patient isorthostatic based on the comparison; predicting an effectiveness or aresponsiveness of renal denervation therapy to the patient based ondetermining that the hypertension in the patient is orthostatic; andproviding the predicted effectiveness or the predicted responsiveness toan operator.
 22. The method of claim 21, further comprising: determiningat least one of a number of ablations or an amount of energy deliveredin each ablation of the number of ablations based on the determinationthat the hypertension in the patient is orthostatic; and applying therenal denervation energy to the patient based on the at least one of thenumber of ablations or the amount of energy delivered in each ablation.